Using SMART Experimental Design to Personalize Treatment for Child Depression
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 44
- 试验地点
- 2
- 主要终点
- Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)
研究概览
简要总结
The purpose of the study is:
- To conduct a pilot SMART (Sequential, Multiple Assignment, Randomized) study with the long-term goal of developing a personalized treatment for child depression.
- To collect pilot data on ways to personalize treatment for child depression using cognitive behavioral therapy (CBT), caregiver-child treatment, or both.
详细描述
Child depression is among the most prevalent and impairing pediatric conditions and constitutes a major public health concern. Unfortunately, treatment benefits are relatively modest and short-lived with sizeable percentages of children who maintain depressive symptoms following treatment. This problem may be addressed in part by personalizing treatment, including determining which children will benefit from CBT, which children will benefit from caregiver-child treatment, and which children will benefit from both. The goal of the current study is to pilot test an innovative experimental design called Sequential, Multiple Assignment, Randomized Trial (SMART), which is used for development of personalized treatments, collect pilot data, and assess the acceptability and feasibility of using this design, in preparation for a full-scale SMART in a larger clinical trial and for the development of personalized treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Factorial
- 主要目的
- Health Services Research
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 7 Years 至 14 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Current diagnosis of Major Depressive Disorder (MDD), Dysthymic Disorder (DD), or Depressive Disorder Not Otherwise Specified (NOS).
- •If receiving psychiatric medication, dose should be stable for at least three months at enrollment.
排除标准
- •A disorder other than depression as primary diagnosis.
- •Autism Spectrum Disorders and Pervasive Developmental Delay or Disorder.
- •Mental Retardation.
- •Psychotic Disorders and Schizophrenia.
- •Mania or Hypomania disorders.
- •Acute suicidal behavior and/or acute plan that require higher level of care, and being hospitalized over the past year for a suicide attempt or for threatening to commit suicide.
- •Participation in additional psychotherapy.
- •Caregiver and/or children do not speak English.
结局指标
主要结局
Schedule for Affective Disorders and Schizophrenia for School-Aged Children-Present and Lifetime Versions (K-SADS-PL)
时间窗: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician-administered semi-structured interview with children and caregivers assessing present episode and lifetime history of psychiatric diagnoses based on DSM-IV criteria.
Children's Depression Inventory 2:Parent (CDI2:P)
时间窗: Pre-treatment, Stage 1, Stage 2, 3-month follow-up, before each session
Parent-report questionnaire assessing child's depressive symptoms.
Children's Depression Rating Scale-Revised (CDRS-R)
时间窗: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician-administered semi-structured child interview of depression.
Children's Depression Inventory 2: Self Report (CDI2:SR)
时间窗: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Child self-report questionnaire assessing depressive symptoms.
Clinical Global Impression (CGI)
时间窗: Pre-treatment, Stage 1, Stage 2, 3-month follow-up
Clinician assessment of child's symptom severity and level of improvement.
次要结局
未报告次要终点
研究者
Dikla Eckshtain, PhD
Instructor in Psychology
Massachusetts General Hospital